Infusion device and method therefor

Abstract

An infusion device and method are provided, the infusion device including: a receptacle configured to receive a syringe; a plunger driver configured to releasably engage an end of a plunger of the syringe; a controller configured to control movement of the plunger driver in at least one direction, the controller configured with functionality including a first function secured using a first authentication that is enabled or not enabled to provide authenticated access; and a user interface having a display and one or more input elements. The first authentication can include an access code that enables a healthcare professional to change settings in the controller to control the infusion according to the settings. The method enables authenticated resetting of the access code.

Description

[Technical Field]

[0001] SUMMARY The present disclosure relates to an infusion device including a controller and a method in an infusion device including controlling access to the controller. [Background technology]

[0002] Introduction Patients with chronic diseases and conditions may require regular intravenous and / or subcutaneous injections of therapeutic medications. For some medication types, this may also require regular injections, as determined by the treating physician. For certain patients, including young patients and those with disabilities, care is often provided in a clinical setting. However, this requires the patient and caregiver to be present at the treatment site. Therefore, many clinics educate patients and caregivers, when possible, so that they can administer intravenous infusions at home. This reduces the burden on all parties. However, difficulties can arise in self-administered procedures, including determining the correct dosage and ensuring that the infusion is administered at the appropriate rate. Improvements to existing methods are desirable.

[0003] Certain treatments involve the infusion of a quantity of reconstituted medication (i.e., a dry drug medication restored to its original state by the addition of a liquid). The amount of reconstituted medication required can depend on many factors, including the type of medication, the patient's condition, and the type or stage of the disease (or condition). For some diseases, such as hemophilia, the presence of clotting factor antibodies can also affect the amount of therapy that must be infused. In addition to the dosage, intravenous therapy must be administered at a controlled rate because of the limitations of a given vein's capacity to accept the medication, as well as the blood flow rate and volume within the vein. Thus, especially when administered via a syringe, it is possible to infuse a therapy into a vein at an excessive rate. This can result in too much medication being infused and even physical damage to the vein. This is especially true for longer duration infusions, which require greater control over longer periods. In extreme cases, excessive flow rates can "burst" or distend the vein, potentially injuring the patient. Therefore, controlling the rate and volume of the infusion is essential. Additionally, certain drugs, including hemophilia drugs, are prohibitively expensive, so administering the correct amount and at the correct rate reduces the likelihood of wasted product and therefore reduces costs.

[0004] In many situations, it is advantageous for the user of an infusion device to have access to the device's controller. For example, dose settings may need to be adjusted under the supervision of a remote Health Care Person (HCP), thereby avoiding the device having to be sent or transported to the HCP or the HCP having to visit the user to adjust settings.

[0005] Many modern infusion devices can be accessed remotely, for example, to change device settings, update software, or for other reasons. For security reasons, it may be required that an access code must be physically entered into the device to allow remote access to the device.

[0006] This means that the user of the device must know the access code, which may constitute a security risk as it allows the user to change the dose setting or other settings on the device without the HCP.

[0007] It is therefore an object of the present invention to provide an infusion device and a method for controlling access to an infusion device that avoids the security risks mentioned above while maintaining the advantages of solutions known in the art. Summary of the Invention

[0008] It is an object of the present invention to provide an infusion device and method therein that allows only authenticated access to at least one protected function in the infusion device, for example, a portable continuous infusion device, but that includes an electronic controller with limited processing capabilities and no communications network access.

[0009] A further objective is to enable only authorized access while complying with data protection regulations, such as the General Data Protection Regulation (GDPR) drafted and approved by the European Union (EU).

[0010] The following is provided: 1. A method in an infusion device, the infusion device comprising: a receptacle configured to receive a syringe; a plunger driver configured to releasably engage an end of a plunger of a syringe; a controller configured to control movement of a plunger driver in at least one direction, the controller configured to have functionality including a first functionality protected using a first authentication that is either enabled or not enabled to provide authenticated access; a user interface having a display and one or more input elements; The method is: In response to a determination that the first authentication requiring an access code value is not enabled, generating a representation code value based on the first value and the second value using a representation code generation algorithm; generating an unlock code value based solely on the display code value using an unlock code generation algorithm; displaying the display code via the display and forgoing displaying the unlock code; receiving a third value input by a user via the input element; enabling access to reset the access code and / or enabling the first authentication via the user interface in accordance with determining that the third value corresponds to the unlock code value; and forgoing enabling access to reset the access code (PIN) and forgoing enabling the first authentication via the user interface in accordance with a determination that the third value does not match the unlock code value.

[0011] An advantage is that the infusion device, e.g., a portable, e.g., body-worn, continuous infusion device, enables resetting an access code value until a correct unlock code value is entered into the infusion device, while reducing the risk of providing unintended access to the first function. In some examples, the first function enables the infusion device to change settings in a controller for controlling the infusion according to the settings. On the one hand, if unintended access to the first function is provided, it may be associated with a serious health risk. On the other hand, if access via the user interface is irreversibly blocked, it may also be linked to a serious health risk.

[0012] In particular, the infusion device enables only authenticated access to at least a first function in the controller. Other functions in the controller may or may not require authentication. In some examples, a healthcare professional (HCP) may be permitted to access the first function to change settings related to a patient's prescription, but no (patient) authorization is required to receive an infusion via the infusion device.

[0013] The HCP can reset the access code value by operating the infusion device via a user interface and entering a code value identical to the unlock code. The HCP can obtain a code value identical to the unlock code from a support facility based on presenting only the display code. Essentially, the display code itself lacks information that reveals the identity of the patient, let alone the identity of the infusion device. This allows the infusion device to enable access to a first function while not revealing or making it impossible to reveal confidential patient-related information.

[0014] Advantageously, the infusion device can be compliant with data protection regulations, such as the General Data Protection Regulation (GDPR). In particular, the infusion device can be an infusion device that includes an electronic controller with only limited processing capabilities and no wired and / or wireless communication network access. The electronic controller can include one or more so-called microcontrollers or complex programmable logic devices. The infusion device typically includes a battery, such as a coin cell or penlight battery.

[0015] The support facility, which may be configured or arranged, for example, in the form of a call center, issues an unlock code value to the identified HCP in response to receiving the display code value. The support facility may require identification or authentication from the HCP as a condition for issuing the unlock code value based on the display code value. Thus, the call center may refuse to issue an unlock code to anyone who does not identify themselves as an HCP, e.g., an HCP registered with the call center. Thus, the HCP, rather than the patient prescribed to receive an infusion from the infusion device, may enter the unlock code and change the settings of the infusion device, e.g., via the first function. The support facility may use a lookup table or an app running on an electronic device to obtain and issue the unlock code value.

[0016] The representative code values ​​can be considered to be pseudorandom codes drawn from a set of a finite number of code values ​​limited to, for example, about 1000 unique values, or the finite number of code values ​​is limited to about 100 unique values ​​or about 10,000 unique values.

[0017] The unlock code value is generated based solely on the display code, and as the display code value changes, the unlock code value changes as well, making attempts to guess the unlock code at best equivalent to statistical sampling with replacement.

[0018] In some instances, for example all instances, the infusion device always forgoes displaying the unlock code value.

[0019] As described above, the first function is protected using a first authentication that may or may not be enabled to provide authenticated access. For example, the first authentication cannot provide authenticated access after a certain threshold number of failed attempts to enter an access code is reached or exceeded. If the first authentication cannot provide authenticated access, the authentication is locked. Once the first authentication is enabled to provide authenticated access, a valid access code provides authentication. For example, the first authentication is enabled to provide authenticated access after an access code reset. For example, each access code ceases to provide the first authentication when the first authentication is not enabled.

[0020] In some embodiments, the method comprises: In response to detecting that the first authentication is enabled to provide authenticated access to the first function, the controller, via the user interface, includes an access code value to enable moving the plunger driver in at least one direction without requiring authentication.

[0021] An advantage is that the patient can use the infusion device for prescribed infusions, for example prescribed continuous infusions, without authentication interference.

[0022] In some examples, a patient requiring a prescribed infusion using an infusion device can operate the infusion device without authentication at the infusion device to receive the prescribed infusion using a first authentication via a user interface in accordance with settings operably protected from alteration.

[0023] In some examples, the first authentication is not enabled to provide authenticated access after a threshold number of failed attempts to enter the access code has been reached or exceeded, and / or before the unlock code is first entered (e.g., if the infusion device has not yet been set up by the HCP), and / or during reset, before a new access code is set.

[0024] In some examples, when it is detected that the first authentication is not enabled to provide authenticated access to the first function, the controller is disabled from moving the plunger driver in at least one direction with or without authentication via the user interface.

[0025] In some embodiments, the method comprises: receiving a fourth value via one or more input elements; enabling access to the first feature in accordance with a determination that the fourth value corresponds to the access code value; and forgoing enabling access to the first feature in accordance with a determination that the fourth value does not match the access code value.

[0026] The advantage is that an HCP who has been delegated the access code value can use the first function to change settings that define, for example, the amount and / or rate and / or frequency of an infusion.

[0027] In some examples, only the HCP is authorized by an authority external to the infusion device to obtain access to the unlock code based on the display code. Thus, for example, in situations where a first authentication protecting a first function ceases to be enabled, for example, when a threshold number of failed authentication attempts is met or exceeded, only the HCP is enabled to reset the access code via a user interface.

[0028] In some embodiments, the method comprises: in response to a determination that the fourth value does not match the access code value; the controller forgoes enabling the plunger driver to move in at least one direction and forgoes enabling the first function; and / or Setting the first authentication to not be enabled includes:

[0029] The advantage is that the risk of allowing an infusion based on an incorrect setting is reduced.

[0030] In some aspects of the method, the first function protected using the first authentication comprises: Receiving one or more inputs corresponding to the settings in the controller via the input element for controlling the infusion at the infusion device according to the settings.

[0031] The advantage is that the risk of infusing an unhealthy dose of medication due to inadvertent manipulation of the infusion device can be prevented or at least reduced.

[0032] In some examples, the first setting of the controller is associated with controlling movement of the plunger driver, hi some examples, the first function in the controller enables the controller to generate a signal that controls movement of the plunger driver in at least a first direction.

[0033] In some embodiments, the method comprises: and setting the first authentication requiring the access code value to not be valid in accordance with reaching and / or exceeding a threshold number of consecutive determinations that the fourth value does not correspond to the access code value.

[0034] The advantage is that the HCP may be allowed several attempts to enter the code correctly, which may give the HCP a better chance of operating the infusion device as intended without compromising prevention of unintended access to the first function.

[0035] In some examples, a determination that one value corresponds to another value includes a determination that the one value is identical to the other value.

[0036] In some examples, the number of consecutive determinations includes fewer than six, eg, fewer than four, consecutive determinations that the third value does not correspond to the unlock code value.

[0037] In some examples, a method in an infusion device includes starting a timer and setting a timer threshold to not enable a first authentication requesting an access code value pursuant to reaching and / or exceeding the timer threshold. The timer may be set to a first time, for example, when a display shows a prompt to enter an access code or when a third value is received via an input element.

[0038] In some embodiments, the method comprises: in response to determining that the third value does not match the unlock code value; generating a new representation code value based on the second value and based on a new acquisition of the first value from the generator; and generating a new unlock code value in response to the newly generated display code.

[0039] The advantage is that the infusion device is not completely and permanently blocked after one or more unsuccessful attempts to enter an unlock code value. Rather, the infusion device remains accessible for successive attempts to enter an unlock code, each time based on a new display code.

[0040] Attempted approaches to gaining access to the first functionality based on repeated attempts to guess the unlock code value are likely to be futile, as the attempted approaches at best correspond to sampling with replacement and not sampling without replacement.

[0041] In some examples, a newly obtained first value from the generator is likely to have a first value that is different from a previous first value. The generator may generate values ​​that have a degree of repeatability, such as pseudo-random values. Thus, the display code value may exhibit a corresponding repeatability.

[0042] In some examples, the newly generated unlock code value overwrites the previously generated unlock code value, and therefore the current unlock code value is the only unlock value for determining whether the third value matches or does not match the unlock code value.

[0043] In some embodiments, the method comprises: Validating the first authentication in response to determining that the third value corresponds to the unlock code value and in response to detecting a reset of the access code.

[0044] The advantage is that before a newly set access code value can provide access to a first function protected using the first authentication, an access code reset is required, which overrides the previous access code value and ceases to provide authentication to the first function.

[0045] In some aspects of the method, the controller is configured to enter one or more states, including a first state, and / or detect one or more events, including a first event, and the method further comprises: Detecting that the controller has entered a first state and / or that a first event has been detected; and and setting a first authentication requiring an access code value to not be enabled in response to detecting that the controller has entered the first state and / or that a first event has been detected.

[0046] The first event may include, for example, the controller being ready after inserting a battery into a battery compartment of the infusion device. The first state may include the controller performing a start-up procedure or completing a start-up procedure after inserting a battery into a battery compartment of the infusion device. In some examples, the first event corresponds to receiving an input via an input element.

[0047] In some aspects of the method, The controller includes a generator that generates a time-varying value; the first value is obtained from a generator that generates time-varying values ​​that include the first value; and The second value is based on a serial number associated with the infusion device.

[0048] An advantage is that this method can be performed by an infusion device that includes an electronic controller with limited processing power and no wired and / or wireless communication network access. The electronic controller may include one or more so-called microcontrollers or complex programmable logic devices. Infusion devices typically include a battery, e.g., a coin cell or penlight battery.

[0049] In some examples, the generator that generates the time-varying value includes a timer that generates a time code, or a counter that operates in an infinite loop and either counts up continuously until reset, or alternately counts up and down.

[0050] In some aspects of the method, the display code generation algorithm combines the first value and the second value into one or more of multiplication, addition, and subtraction, but not division; and Combining based on bit shifting.

[0051] An advantage is that the controller can generate the display code using the display code generation algorithm based only on limited processing resources, which may be limited in terms of, for example, processing speed, memory, arithmetic logic unit, and bit width.

[0052] In some examples, the first code and the second code are combined using one or more of multiplication, addition, and subtraction. In some examples, the representation code value is generated via a bit shift operation.

[0053] The controller of the infusion device is configured to generate the display code based on, for example, additions and bit shifts, where the bit shifts can be applied to any of the values ​​before or after the additions and / or subtractions and / or multiplications.

[0054] The advantage is improved security. In some examples, a valid access code value enables access to more frequently used features of the infusion device, while an unlock code enables access to first-time use of the infusion device or access to renew the usage period.

[0055] In some examples, the first function does not include one or more functions that enable the controller to generate a signal that controls movement of the plunger driver.

[0056] In some aspects of the method, the time-varying value is repeatedly increased or decreased at a rate faster than once per 30 minutes, e.g., faster than once per minute, e.g., faster than once per second.

[0057] In some aspects of the method, the time-varying value is repeatedly increased or decreased at a rate slower than once per 100 milliseconds, e.g., at a rate of once per second or less, e.g., at a rate slower than once per minute.

[0058] The advantage is that the risk of drawing the same display code more than once in succession is reduced.

[0059] In some examples, the time-varying value corresponds to a time, including a time of day or a date.

[0060] In some examples, the display code comprises a three-digit value. In some embodiments, the unlock code comprises a four-digit value.

[0061] In some aspects of the method, the display code value comprises a first number of characters, and the unlock code comprises a second number of characters, the second number of characters being different from the first number of characters.

[0062] The advantage is that the risk of an HCP confusing the display code with the third code value corresponding to the unlock code is reduced.

[0063] In some examples, the first display code value consists of three, four, or five characters, and the unlock code consists of four, five, or six characters.

[0064] In some aspects of the method, the infusion device is associated with a support facility, and the method further comprises: At the support facility, receiving a value corresponding to the display code; determining a code value identical to the unlock code value based on a value corresponding to the display code and an implementation of an unlock code generation algorithm; and delivering a third value to the user based on the same code value as the unlock code value.

[0065] An advantage is that the support facility can provide the unlock code value without obtaining information including the code value, without revealing the serial number of the infusion device, and without revealing information identifying the patient who will use the infusion device to receive the infusion. The support facility is configured or arranged to issue the unlock code value in response to receiving the display code value.

[0066] Support facilities may operate under unpublished telephone numbers and / or require pre-registration of HCPs, which significantly reduces the risk of revealing access codes to unauthorized individuals.

[0067] The support facility is separate from the infusion device, for example, the support facility is operated from a remote location.

[0068] In some aspects of the method, the support facility includes a call center.

[0069] The call center can use a lookup table or an app running on the electronic device to determine the third value based on a code value identical to the unlock code value.

[0070] Also provided are: 1. An infusion device comprising: a receptacle configured to receive a syringe; a plunger driver configured to releasably engage an end of a plunger of a syringe; a controller configured to control movement of a plunger driver in at least one direction, the controller configured to have functionality including a first functionality protected using a first authentication that is either enabled or not enabled to provide authenticated access; a user interface having a display and one or more input elements; The method is adapted to carry out the method according to any one of claims 1 to 12.

[0071] Also provided are: 1. A computer-readable medium, comprising: and computer readable instructions that, when executed by a controller in an infusion device, cause the infusion device to perform the method of any one of claims 1 to 12, wherein the infusion device: a receptacle configured to receive a syringe; a plunger driver configured to releasably engage an end of a plunger of a syringe; a controller configured to control movement of a plunger driver in at least one direction, the controller configured to have functionality including a first functionality protected using a first authentication that is either enabled or not enabled to provide authenticated access; and a user interface having a display and one or more input elements.

[0072] Various embodiments will now be described with reference to the drawings. Like reference numerals refer to like elements throughout. Therefore, like elements will not be described in detail with respect to the description of each figure. It should also be noted that the drawings are intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the claimed invention or as limiting the scope of the claimed invention. In addition, the illustrated example need not have all aspects or advantages shown. An aspect or advantage described in connection with a particular embodiment is not necessarily limited to that embodiment and may be implemented in any other embodiment, even if not so illustrated. [Brief explanation of the drawings]

[0073] [Figure 1A] 1 shows an example of an infusion device. [Figure 1B] 1 shows an example of an infusion device. [Figure 1C] 1 shows the housing of the infusion device. [Figure 1D] 1 shows infusion using a syringe connected to an infusion line. [Figure 1E] 1A and 1B show some of the internal components of the infusion device shown in FIG. [Figure 1F] 1A and 1B show some of the internal components of the infusion device shown in FIG. [Figure 1G] 1A and 1B show some of the internal components of the infusion device shown in FIG. [Figure 1H]1A and 1B show some of the internal components of the infusion device shown in FIG. [Figure 1I] 1C illustrates a schematic of the relationship between some of the internal components of the infusion device shown in FIGS. 1A and 1B. [Figure 2] 10 is a flowchart showing a procedure for changing an access code. [Figure 3] Here is an example of how the display code can be calculated: [Figure 4A] 10 is a flowchart showing a procedure for changing an access code. [Figure 4B] 1 shows a table used to determine the unlock code. [Figure 5] 1 shows a flowchart of a first method performed by a controller to enable authenticated reset of an access code. [Figure 6] 10 shows a flowchart of a second method executed by the controller to allow authenticated access to functions in an infusion device and resetting the access code. DETAILED DESCRIPTION OF THE INVENTION

[0074] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. In this regard, the embodiments may have different forms and should not be construed as limited to the description set forth herein. Accordingly, the embodiments are simply described below with reference to the drawings to illustrate aspects. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. Expressions such as "at least one," when preceding a list of elements, modify the entire list of elements, and not individual elements of the list.

[0075] In the drawings, the thicknesses of several layers and regions are shown in an exaggerated format for clarity and ease of illustration. When a layer, region, element, or plate is referred to as being "on" another layer, region, element, or plate, it may be directly on the other layer, region, element, or plate, or there may be intervening layers, regions, elements, or plates therebetween. Conversely, when a layer, region, element, or plate is referred to as being "directly on" another layer, region, element, or plate, there are no intervening layers, regions, elements, or plates therebetween. Furthermore, when a layer, region, element, or plate is referred to as being "under" another layer, region, element, or plate, it may be directly under the other layer, region, element, or plate, or there may be intervening layers, regions, elements, or plates therebetween. Conversely, when a layer, region, element, or plate is referred to as being "directly beneath" another layer, region, element, or plate, there are no intervening layers, regions, elements, or plates present.

[0076] The spatially relative terms "lower" or "bottom" and "upper" or "top," "below," "beneath," "less," "above," and the like may be used for ease of description to describe the relationship between one element or component and another element or component as shown in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation shown in the figures. For example, if a device shown in the figures is rotated, an element described as being on the "lower" side of other elements, or another element "below" or "lower," would be oriented on the "upper" side of, or another element "above." Thus, the exemplary terms "lower" or "lower" can encompass both "lower" and "upper" orientations, depending on the particular orientation of the figure. Similarly, if the device in one of the figures were turned over, elements described as "below" or "lower" of other elements would be oriented "above" the other elements. Thus, the terms "below" or "lower" can encompass both an orientation of above and below, and thus spatially relative terms may be interpreted differently depending on the orientation described.

[0077] Throughout this specification, when an element is said to be "connected" to another element, the element may be "directly connected" to the other element or "electrically connected" to the other element with one or more intervening elements therebetween.

[0078] The terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. As used herein, the singular forms "a," "an," and "the" may also be intended to include "at least one," unless the context clearly indicates otherwise. "At least one" should not be interpreted as limiting "a" or "an." It will be further understood that the terms "comprises," "comprising," "includes," and / or "including" specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0079] It will be understood that the terms "first," "second," "third," and the like may be used herein to describe various elements, but these elements should not be limited by these terms. These terms are used only to distinguish one element from another. Thus, a "first element" described below may be referred to as a "second element" or a "third element," and "second element" and "third element" may be similarly referred to without departing from the teachings of this specification.

[0080] As used herein, "about" or "approximately" encompasses stated values ​​and means within an acceptable range of deviation for a particular value as determined by one of ordinary skill in the art, and encompasses the error associated with the measurement and measurement of the particular quantity (i.e., the limitations of the measurement system). For example, "about" can mean within one or more standard deviations, or within ±30%, 20%, 10%, 5% of the stated value.

[0081] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0082] Illustrative examples are described herein with reference to cross-sectional illustrations that are schematic illustrations of idealized embodiments, where like reference numerals refer to like elements throughout. As such, variations from the shapes of the illustrations are to be expected as a result, for example, of manufacturing techniques and / or tolerances. Accordingly, the embodiments described herein should not be construed as limited to the particular shapes of regions as illustrated herein but are to include, for example, deviations in shapes that result from manufacturing. For example, a region illustrated or described as flat may have rough and / or non-linear features. Furthermore, sharp angles shown may be rounded. Accordingly, regions illustrated in the figures are schematic in nature, and their shapes are not intended to illustrate the precise shape of the regions and are not intended to limit the scope of the claims. To specifically illustrate illustrative embodiments of the present disclosure, some components not associated with the description may not be provided.

[0083] 1A and 1B show an example of an infusion device 100 having a syringe 200 with a plunger 202, according to one example of the present invention. While FIG. 1B shows the infusion device 100 and syringe 200 side-by-side, in FIG. 1A, the syringe 200 is positioned within the infusion device 100 such that the plunger 202 is not visible in this view. The syringe 200 can be supported within a receptacle 120, shown in FIG. 1C, such that an end of the syringe 200 and / or an infusion line coupled to the syringe 200 extends through the distal end of the infusion device 100. The syringe 200 supported within the receptacle 120 is shown in FIGS. 1A and 1D, which shows an infusion line 210 coupled to the syringe 200.

[0084] In one or more examples, syringe 200 may be a typical over-the-counter syringe with plunger 202 that is movable, e.g., by hand, for administering a fluid and / or therapeutic agent (e.g., a medication or drug, such as a reconstituted drug), e.g., subcutaneously or intravenously. In other examples, syringe 200 may be a specially designed syringe that is particularly suited, e.g., for administering a therapeutic agent. Furthermore, syringe 200 may be pre-filled with a medication, i.e., not require a syringe-filling application, where a user typically fills the syringe by drawing a medication / drug from a primary container vial.

[0085] The infusion device 100 may be worn, for example, by a patient. The infusion device 100 may be coupled to an infusion line 210, as shown in Figure ID. The infusion line 210 is coupled to a needle 212 having a needle outlet 214 through which medication exits the syringe infusion line 210.

[0086] The infusion device 100 as shown in FIGS. 1A-1B includes a housing 122 having a receptacle 120 therein for receiving a syringe 200. The receptacle 120 can thus be configured to support the syringe 200 and control the syringe 200 for administration of a medication to and from the syringe 200. An example of the housing 122 and receptacle 120 is shown in FIG. 1C, which shows the housing 122 in an open and empty state. The housing 122 includes an upper housing portion 124 and a lower housing portion 126. The upper housing portion 124 of the infusion device 100 is movable relative to the lower housing portion 126, allowing access to the interior of the infusion device 100 for mounting the syringe 200 therein. The upper housing portion 124 can be secured onto an upper edge of the lower housing portion 126 and can define an interior space of the infusion device 100 when in a closed state. The housing top 124 may be connected to the housing bottom 126 by one or more hinges 128, allowing the housing top 124 to rotate relative to the housing bottom 126 when transitioning between the open and closed states. In conjunction with the hinges 128, one or more latches or connectors may also be disposed along the edges of the housing top 124 or housing bottom 126 to secure the housing top 124 to the housing bottom 126. One or more latches not shared with the hinge(s) 128 may also be disposed on the edges of the housing bottom 126 and / or housing top 124. The housing top 124 preferably can be opened by pivoting about the hinges 128 to expose the interior space of the infusion device 100 when inserting or removing the syringe 200 from the infusion device 100. The receptacle 120 may preferably extend along a substantial portion of the infusion device 100, but the length of the receptacle 120 may be configured to accommodate the syringe 200 and plunger 202 when the plunger 202 is fully extended and positioned within the receptacle 120.However, it is also contemplated that the receptacle 120 may be formed solely by the syringe opening 101 in the infusion device 100, which may solely support the syringe 200.

[0087] Also shown in FIGS. 1A-1B is a user interface 102 on the exterior of the housing top 124 (see FIGS. 1A-1B), which is configured to allow a user, such as a healthcare professional, to access and adjust settings of the controller 112 of the infusion device 100, for example, by entering a code. In addition to the user interface 102, a set of plunger movement controllers 103 are also shown in FIGS. 1A-1B. The plunger movement controllers 103 may be configured to control the movement of a plunger 104 (see FIGS. 1F-1H) inside the infusion device 100.

[0088] The infusion device 100 includes several internal components, as shown in FIGS. 1E-1H. FIG. 1E illustrates how the plunger driver 104 of the infusion device 100 interacts with the plunger 202 of the syringe 200, with the plunger 202 in contact with the drug compartment 204 of the syringe 200. The plunger driver 104 is configured to releasably engage the driver end 203 of the plunger 202 and move the plunger 202 longitudinally of the syringe 200. The drug compartment 204 may have a generally cylindrical shape, although other shapes are also envisioned. A portion of the drug compartment 204 may be disposed within the infusion device 100, while a remainder of the drug compartment 204 may protrude through the syringe opening 101. The plunger 202 may be slidably received within the drug compartment 204. For example, drug compartment 204 may include a generally hollow elongated enclosure, and plunger 202 may be slidingly disposed within the enclosure within drug compartment 204. Plunger 202 may extend from a driver end 203 disposed outside drug compartment 204 to a drug end 205 disposed within drug compartment 204. Drug end 205 of plunger 202 may contact a movable seal 206 along with drug compartment 204.

[0089] In addition to having a plunger rod attached to the syringe, the syringe may optionally be attached without a plunger rod, in which case the plunger (or piston) in the pump is instead shaped to allow it to be pushed into the syringe body during delivery of the agent / drug to the patient. Using a syringe without a plunger rod can allow for other methods of attaching the syringe in the pump, for example, by axially loading the syringe from the front end of the pump (not shown).

[0090] FIG. 1E also shows how the plunger driver 104 is driven by a drive train 105 comprising a rotary motor 106, such as a DC motor, via a lead screw 108, which is connected to the motor 106 through a gear mechanism comprising one or more gears 110.

[0091] The plunger interface between the plunger driver 104 and the plunger 202 may be configured as a “push-only” interface that moves forward longitudinally to empty the syringe, as shown in three stages in FIGS. 1F-1H . However, the plunger interface may also be implemented for both pushing and pulling, allowing the pump to support aspiration (using an intravascular needle) and / or filling the syringe from a primary container, such as an external vial. Accordingly, the lead screw 108 may be configured to engage the driver end 203 of the plunger 202 and move the plunger 202 in a first direction. The lead screw 108 may also be configured to move the plunger 202 in a second direction opposite the first direction. The lead screw 108 may be configured to engage and / or grip the driver end 203 of the plunger 202 when the driver end 203 is positioned adjacent or near the lead screw 108. Gripping of the driver end 203 may be achieved by the lead screw 108 being connected to or including a gripping arrangement (not shown) that grips the driver end 203 of the plunger.

[0092] 1A-1B allows a user to provide input to the infusion device 100, thereby controlling the movement of the plunger 202 of the syringe 200, when the syringe 200 is supported within the infusion device 100. The plunger movement controller 103 may include two push buttons, one for each opposing direction, which, when pressed, may provide input to the controller 112 (see FIG. 1I) of the infusion device 100 to control the movement of the plunger 202 in a first direction or a second direction. The placement of the plunger movement controller 103 around a central region of the infusion may allow a user to hold the infusion device 100 in one hand and provide input to the plunger movement controller 103 with the user's thumb. As an alternative to the two plunger movement controllers 103 shown in Figures 1A-1B, a joystick that can be moved and / or tilted in two opposite directions to move the plunger 202 in a first direction or a second direction can also be envisioned.

[0093] The user interface 102 may include a digital display and / or a touchscreen display. Alternatively, or in addition to the user interface 102 and plunger movement controller 103 shown in FIGS. 1A-1B, additional user controls may be envisioned. These may include buttons, switches, or any other interface configured to receive input from a user and provide signals to the controller 112 of the infusion device 100. In some examples, the user controls may comprise a mechanical and / or electronic interface capable of receiving input from a user's touch or a user-imposed movement and providing signals to the controller 112 of the infusion device 100. Exemplary electronic interfaces include resistive touch interfaces, capacitive interfaces, or equivalent interfaces. Additionally, the user controls may be integrated into the user interface 102 via a touchscreen display. The user controls and the user interface 102 may preferably be disposed external to the infusion device 100.

[0094] Figure 1I shows a schematic diagram of the relationships between the internal components 102, 104, 106, 108, 110, and 112 of the infusion device. Also shown in Figure 1I is a main controller 112. The gear mechanism, which includes one or more gears 110, may include a planetary gear set 110b and two gears 110a, as shown in Figure 1I. Also shown in Figure 1I are an orientation sensor 114, an orientation sensor self-test system 115, a battery 116 that powers the infusion device 100, a driver 117, and a current measurement sensor 118.

[0095] The motor 106 can drive the lead screw 108. The motor 106 can be controlled by the plunger movement controller 103, a user control, and / or by one or more signals generated from a control algorithm stored in the main controller 112.

[0096] The drive train 105 includes a lead screw 108 that can be configured to be rotated by the motor 106, translating the lead screw 108 in a first direction or a second direction based on the direction of rotation of the lead screw 108. The lead screw 108 preferably extends along the length of the infusion device 100 such that the position of the lead screw 108 along the length of the receptacle 120 is controllable. The length of travel of the lead screw 108 can be determined by the length of the lead screw 108. The lead screw 108 can be configured to engage the driver end 203 of the plunger 202 when the plunger 202 is fully extended from the drug compartment 204, fully inserted therein, or anywhere in between. Thus, the lead screw 108 can be configured to engage the extended plunger 202 and drive the plunger 202 fully into the syringe compartment 204 of the syringe 200 to administer and / or otherwise expel the entire contents of the syringe 200. Similarly, the lead screw 108 may be configured to engage the plunger 202 regardless of how deeply the plunger 202 is inserted into the drug compartment 204 and retract the plunger 202 within the syringe compartment 204 of the syringe 200 to load and / or otherwise fill the syringe 200.

[0097] The motor 106 of the infusion device 100 may receive input from the plunger movement controller 103 and may directly drive the lead screw 108 or may indirectly drive the lead screw 108 via the drive train 105 .

[0098] The drive train 105 may include one or more gears 110 to reduce or increase the rotational speed and torque of the motor 106 at the lead screw 108. The relative size of each gear may vary based on the desired gear reduction or increase between the motor 106 and the lead screw 108 and the expected loads imposed on the gears.

[0099] The lead screw 108 may preferably include a threaded outer surface having a thread pitch and a thread direction. The lead screw 108 may be coupled to a gear 110, whereby as the gear 110 rotates, the threads of the lead screw 108 may impart translation to the lead screw 108 along its length.

[0100] The motor 106 that imparts rotation to the lead screw 108 can control the direction and speed of rotation of the lead screw 108, thereby controlling the position of the lead screw 108. The plunger movement controller 103 can send signals to the motor 106 to control the direction and speed of movement of the plunger driver. The plunger movement controller 103 can also control the lead screw 108 when it is attached to the plunger 202 and when it is otherwise moved or positioned within the infusion device 100.

[0101] During an infusion procedure, the controller 112 may utilize input from the plunger movement controller 103, or in other examples, may receive input only from a user control and a stored algorithm in memory. For example, rather than allowing the user to control the rate at which fluid and therapeutic agent are administered, it may be desirable to control the infusion using a predetermined infusion algorithm stored in memory. For example, certain therapeutic agents may require specific infusion rates based on different variables. These variables may be related to the user's characteristics (e.g., height, weight, blood tests, etc.) as well as the type of fluid or therapeutic agent being infused. Thus, it may be desirable to carefully control the infusion rate without allowing the user to interfere, for example, by accelerating or slowing down the infusion. In this situation, an algorithm stored in memory may be executed by the controller 112, which may execute a particular sequence by sending signals to the plunger driver assembly to control the movement of the lead screw 108 and, therefore, the movement of the syringe plunger 202. The particular algorithm selected for the infusion and the variables that serve as inputs for the algorithm may be loaded into memory or provided to the controller 112 in a variety of ways. For example, the user controls and / or user interface 102 may allow the user to manually input the characteristics necessary to determine the infusion rate (e.g., by selecting a therapeutic agent to be infused, entering information about the user, etc.). The user interface 102 may prompt the user for the necessary inputs, the display itself (e.g., a touchscreen display) may be used, or the user controls may be utilized to respond to prompts before the infusion begins. Alternatively, the infusion variables for the infusion algorithm may be pre-loaded or loaded when needed using an alternative data transfer protocol that does not rely on manual entry using the infusion device 100.

[0102] For example, the infusion device 100 may include a serial interface, near field communication (e.g., RFID, Bluetooth, Wi-Fi, etc.), or equivalent wired or wireless data transfer protocol for transferring information related to an algorithm that may be stored in memory for execution by the controller 112. In some examples, the infusion device 100 may have an NFC reader that can wirelessly read infusion variables or other information from a label or other instructions on a vial containing a fluid and / or therapeutic agent. A third-party device, such as a smartphone or PC computer, may also be used to prepare the algorithm and input the necessary variables, after which the algorithm may be transferred to the infusion device 100 for execution by the controller 112. It will be appreciated that a combination of inputs may be utilized to select and configure the infusion algorithm used to perform the infusion. The algorithm may also operate completely independently of user input (e.g., from the plunger movement controller 103 or input via a user control) during execution, or the controller 112 may accept and process input from the user to modify, stop, or start the infusion algorithm.

[0103] In examples where the input may alter the infusion algorithm, user controls, such as buttons, switches, or a touchscreen interface, may be used to increase the infusion rate, decrease the infusion rate, start the infusion, stop the infusion, etc. Alternatively, input may be provided using plunger movement controller 103. During the infusion, the user may also receive feedback from infusion device 100 in the form of visual, auditory, and / or tactile responses. In one or more examples, user interface 102 may provide the user with visual information regarding the infusion settings and their progress, or may provide any other instructions needed during, before, or after the infusion. For example, user interface 102 may display images, icons, and / or text to provide the user with instructions regarding the use of infusion device 100. Additionally, user interface 102 may indicate the current status of the infusion or provide instructions for operating plunger movement controller 103 before, during, or after the infusion. Additionally, these functions may be provided using indicators which may include audible noise generators, tactile feedback devices such as vibration devices, or equivalent devices that provide audible or tactile feedback to the user.

[0104] Figure 2 is a flowchart showing the procedure for changing the access code. Please note that the PUK code shown in the figure is the same as the unlock code in the claims, and the PIN shown in the figure is the same as the access code in the claims.

[0105] In the illustrated embodiment, the controller 112 of the infusion device 100 generates a three-digit display code using a display code generation algorithm that takes as input the actual time and the serial number of the infusion device 100. The display code is displayed to the user of the infusion device 100, in this case the HCP, and is used as input for the unlock code generation algorithm. The four-digit unlock code generated by the unlock code generation algorithm is not displayed to the user of the infusion device. The HCP communicates the generated display code, along with the serial number of the infusion device 100, to a support function. Using this information, the support function generates an unlock code using the same unlock code generation algorithm as the infusion device 100, whereby the two independently generated unlock codes will be identical. The support function returns the generated unlock code to the HCP, who can now use it to unlock the infusion device 100 and select a new access code. If the HCP enters an incorrect unlock code five times in a row, i.e., an unlock code that does not match the one generated within the infusion device 100, a new display code will be generated and displayed, and the procedure will start again from the beginning.

[0106] 3 shows the display code generation algorithm, which generates a three-digit display code from the actual time and the serial number of the infusion device 100. In the illustrated embodiment, the actual time and the serial number (both represented as 32-bit unsigned integers) are added together. This sum is then logically bit-wise shifted three times to the right, and the last three decimal digits represented by the result of this shift constitute the display code.

[0107] FIG. 4A is a flow chart illustrating a procedure for changing the access code, according to one embodiment of the present invention. In the illustrated embodiment, the infusion device 100 generates an indicator code ( 2 1 7) The medical professional then calls the support line and communicates this display code to the support person. The support person then enters the column 7 and 21 and enter your 4-digit unlock code ( 4 5 1 3 ) and communicates this unlock code to the medical professional, who can then use it to unlock the controller 112 of the infusion device 100 and set a new access code.

[0108] The table referenced in the above description of Figure 4A may be similar to that shown in Figure 4B. In the illustrated embodiment, only 30 of which are shown, the table contains 100 rows and 10 columns, providing a simple means of converting a three-digit display code to a four-digit unlock code by simply using the first two digits of the display code as a row index and the last digit of the display code as a column index to find the cell in the table containing the correct unlock code. In the illustrated example, the display code 2 1 7 refers to row 21 and column 7, where the unlock code 4 5 1 3 is found.

[0109] If 1,000 different unlock codes for a given infusion device 100 are found by running an unlock code generation algorithm for a given serial number and each of 1,000 possible display codes, the use of such a table greatly reduces the complexity of the task imposed on support personnel when asked to provide an unlock code for a given infusion device.

[0110] The reference symbols used above include infusion device 100, infusion device syringe opening 101, user interface 102, plunger movement controller 103, plunger driver 104, drive train 105, motor 106, lead screw 108, gear mechanism, gear 110, gear 110a, planetary gear set 110b, controller 112, orientation sensor 114, orientation sensor self-test system 115, battery 116, driver 117, current measurement sensor 118, receptacle 120, housing 122, housing upper portion 124, housing lower portion 126, hinge 128, syringe 200, plunger 202, driver end of plunger 203, drug compartment 204, drug end of plunger 205, movable seal 206, syringe outlet 208, infusion line 210, needle 212, needle outlet 214.

[0111] The user interface 102 is also referred to herein as a display. The plunger movement controller 103 is also referred to herein as an input element. The display and input elements are collectively referred to as a user interface (UI).

[0112] 5 shows a flowchart of a first method performed by a controller to enable authenticated reset of an access code. In step 500, a display code (DC) is generated using a display code generation algorithm. Step 500 may be performed in response to detecting that the controller has entered a first state and / or detecting that a first event has been detected. In step 500, a first authentication may not be enabled. Step 500 may be reached from the point indicated by the capital letter "A" (see FIG. 6).

[0113] Step 500 receives a first value from a generator that generates a time-varying value (TVC) in step 501 and a second value SN based on the serial number of the infusion device. The generator responds with the first value in response to the request for the time-varying value. The display code generation algorithm may generate a display code DC by combining the first value and the second value based on one or more of multiplication, addition, subtraction, and bit shifting, without division. The display code is displayed via a display of the user interface UI in step 503.

[0114] In step 502, the method generates an unlock code value (ULC) based solely on the display code value using an unlock code generation algorithm. The unlock code algorithm is configured to correspond to the implementation of the unlock code algorithm at the support facility, such that the unlock code generation algorithm at the controller and the support facility can generate identical pairs of display code values ​​and unlock code values. Thus, the unlock code generation algorithm represents a shared secret between the controller and the support facility. The unlock code value is not displayed via the display of the infusion device.

[0115] Step 504 receives a value entered by the HCP or another person at the user interface via input element 103. Input element 103 is also shown. As described herein, the HCP obtains the third value via a support facility. In step 505, the method determines whether the third value corresponds to the unlock code value ULC (Y) or does not correspond to the unlock code value ULC (N). The ULC is stored in the controller.

[0116] In accordance with a determination in step 505 that the third value corresponds to the unlock code value, the method proceeds via step 506 and enables access via the user interface to reset the access code and / or enables the first authentication via at least step 508. The method may proceed from step 508 via point "C". Similarly, in accordance with a determination in step 505 that the third value does not match the unlock code value, the method proceeds via step 506 and forgoes enabling access via the user interface to reset the access code and forgoes enabling the first authentication via at least step 507. The method may proceed from step 507 via point "B" to resume at point "A". As referred to herein, an access code may also be referred to as a PIN code, and an unlock code may also be referred to as a PUK code, for example a dynamic PUK code.

[0117] Following the authenticated reset of the access code described above, the following relates to obtaining authentication via an access code or initiating a reset of the access code.

[0118] 6 shows a flowchart of a second method executed by the controller for enabling authenticated access at the infusion device and resetting the access code. The second method reaches point "A" (see also FIG. 5) if authentication fails and point "F" if authentication is successful. As noted above, point "A" results in an authenticated reset of the access code (see also FIG. 5).

[0119] Point "F" is reached via step 608, which provides access to a first function that allows for changing settings in the controller for controlling the infusion in the infusion device according to the settings. Through point "F", the method may allow the controller to move the plunger driver in at least one direction without requiring approval via the user interface.

[0120] However, the second method begins at point "E" or point "C" (see Figure 5). Point "E" involves accessing a first function by entering an access code value, while point "C" involves a reset followed by entering a new access code value (see Figure 5).

[0121] Point "E" leads to steps 601 and 603, where the method displays a prompt to enter an access code value via a display of the user interface UI. In step 604, a fourth value is received via an input element of the user interface UI. In step 606, it is determined whether the fourth value corresponds or does not correspond to the stored access code value PIN. In accordance with a determination that the fourth value corresponds to the access code value PIN (Y), the method provides access to a first function via step 607. As described above, the first function allows the infusion device to change settings in a controller for controlling the infusion according to the settings. Alternatively, in accordance with a determination that the fourth value does not correspond to an access code value (N), the method forgoes providing access to the first function via step 607. This is done by not allowing the first authentication to provide authenticated access. In this case, settings cannot be changed via the first function. Additionally, the method may further prevent the controller from moving the plunger driver in at least one direction until at least the access code is reset. Following a determination that the fourth value does not correspond to an access code value (N), the method may proceed to step 609 to determine whether a threshold number of failed attempts to enter an access code value (N) has been met or exceeded. If the threshold has not been met or exceeded (N), the method may resume at step 604 to provide the user with another opportunity to enter an access code. Alternatively, if the threshold has been met or exceeded (Y), the method may proceed to step 610 described above.

[0122] Point "C" leads to steps 602 and 603, where the method displays a prompt to enter a new (reset) access code value via a display in the user interface UI. In step 604, a fourth value is received via an input element in the user interface UI. In this case, the fourth value represents the new (reset) access code, which is stored in step 605. The method can then proceed to point "E".

[0123] The present invention is further described in the following sections. 1. An infusion device comprising: a receptacle configured to receive a syringe; a plunger driver configured to releasably engage an end of a plunger of a syringe; a controller configured to generate signals to control movement of the plunger driver in at least one direction; a user interface configured to enable a user, e.g., a healthcare professional, to enter a code and, after entering a valid access code, to access and adjust the settings of the controller; The controller Whenever you need to reset or change your valid access code, generating a display code using a display code generation algorithm, the display code being displayed on a user interface; and an infusion device configured to generate an unlock code using an unlock code generation algorithm, wherein the unlock code is not displayed on a user interface.

[0124] 2. The infusion device of item 1, wherein the display code generation algorithm generates the display code based on the current time and the serial number of the infusion device.

[0125] 3. An infusion device according to item 1 or 2, wherein the unlock code generation algorithm generates an unlock code based on the display code and the serial number of the infusion device.

[0126] 4. The infusion device according to any one of items 1 to 3, wherein the display code consists of a certain number of characters, such as 3, 4, or 5 characters.

[0127] 5. An infusion device according to any one of items 1 to 4, wherein the unlock code consists of a certain number of characters, such as 4, 5, or 6 characters.

[0128] 6. An infusion device according to any one of items 1 to 5, wherein the number of characters in the unlock code is different from the number of characters in the display code.

[0129] 7. An infusion device according to any one of items 1 to 6, wherein the controller is configured to change the valid access code each time the access code is used to access the controller of the infusion device.

[0130] 8. The infusion device of any one of items 1 to 6, wherein the access code is valid until the next display code is generated by the display code generation algorithm or until the expiration of a limited period of time, such as 2 minutes, 5 minutes, or 10 minutes, calculated from the time of generation of the most recent display code by the display code generation algorithm, whichever comes first.

[0131] 9. An infusion device as described in item 8, wherein the generation of the display code by the display code generation algorithm and the generation of the unlock code by the unlock code generation algorithm are initiated by a user of the infusion device, for example by pressing a button.

[0132] 10. An infusion device according to any one of items 7 to 9, wherein the valid access code is identical to the most recent unlock code generated by the unlock code generation algorithm.

[0133] 11. An infusion device described in any one of items 1 to 6, wherein the controller is configured to reset the valid access code if an incorrect access code is entered multiple times, such as three, four, or five times, after a valid access code has been entered.

[0134] 12. An infusion device described in any one of items 7 to 9 and 11, wherein when the valid access code is reset, the user can enter a new valid access code by entering the unlock code generated by the unlock code generator.

[0135] 13. An infusion device as described in item 12, wherein the controller is configured to generate a new display code and a new unlock code if an incorrect unlock code is entered multiple times, such as three, four, or five times.

[0136] 14. A method for controlling access to a controller of an infusion device, the method comprising: a receptacle configured to receive a syringe; a plunger driver configured to releasably engage an end of a plunger of a syringe; a controller configured to generate signals to control movement of the plunger driver in at least one direction; a user interface configured to enable a user, e.g., a healthcare professional, to enter a code and, after entering a valid access code, to access and adjust the settings of the controller; the controller is further configured to be able to reset or change the valid access code; This method is Whenever you need to reset or change your valid access code, generating a display code using a display code generation algorithm, the display code being displayed on a user interface of the infusion device; and - generating an unlock code using an unlock code generation algorithm, wherein the unlock code is not displayed on a user interface of the infusion device.

[0137] 15. The method according to item 14, wherein the step of generating a display code generates the display code based on the current time and the serial number of the infusion device.

[0138] 16. The method according to item 14 or 15, wherein the step of generating an unlock code generates the unlock code based on the display code and the serial number of the infusion device.

[0139] 17. The method according to any one of items 14 to 16, wherein the step of generating a display code generates a display code consisting of a certain number of characters, such as three characters, four characters, or five characters.

[0140] 18. The method according to any one of items 14 to 17, wherein the step of generating an unlock code generates an unlock code consisting of a certain number of characters, such as 4 characters, 5 characters, or 6 characters.

[0141] 19. The method according to any one of items 14 to 18, wherein the number of characters in the generated unlock code is different from the number of characters in the generated display code.

[0142] 20. A method according to any one of items 14 to 19, wherein the steps of generating a display code and generating an unlock code are performed each time a valid access code is used to access the controller of the infusion device.

[0143] 21. The method according to any one of items 14 to 19, wherein the access code is valid until the next display code is generated by the display code generation algorithm or until the expiration of a limited period of time, such as 2 minutes, 5 minutes, or 10 minutes, calculated from the time of generation of the most recent display code by the display code generation algorithm, whichever comes first.

[0144] 22. The method of claim 21, wherein the steps of generating the display code and generating the unlock code are initiated by a user of the infusion device, for example by pressing a button.

[0145] 23. The method according to item 20 or 21, wherein the steps of generating a display code and generating an unlock code are followed by a step of modifying the valid access code to be identical to the unlock code generated in the step of generating an unlock code.

[0146] 24. The method according to any one of items 14 to 19, wherein the steps of generating a display code and generating an unlock code are performed if an incorrect access code is entered multiple times, such as three, four, or five times, after a valid access code has been entered.

[0147] 25. The method according to any one of items 20 to 22 and 24, wherein the step of generating a display code and the step of generating an unlock code are followed by a step of allowing a user to enter a new valid access code when the unlock code generated in the step of generating an unlock code is entered.

[0148] 26. The method of item 25, wherein the steps of generating a display code, generating an unlock code, and allowing the user to enter a new valid access code are repeated if an incorrect unlock code is entered multiple times, such as three, four, or five times.

[0149] 27. The method of any one of items 14 to 26, wherein the method is performed by a controller of an infusion device of any one of items 1 to 13.

[0150] In this way, an infusion device according to the first item allows, for example, the access code to be changed whenever the access code has been used. However, because only a display code, which is not identical to the new access code, is displayed to the user, the user must contact an authorized person, typically an HCP, to receive an unlock code, which may be identical to the new access code. Thus, the user can access the device's controller, but only if they have already contacted an HCP or another authorized person.

[0151] Thus, the method according to the second item allows, for example, changing an access code whenever it has been used. However, because only a display code, which is not identical to the new access code, is displayed to the user, the user must contact an authorized person, typically an HCP, to receive an unlock code, which may be identical to the new access code. Thus, the user can access the device's controller, but only if they have already contacted an HCP or another authorized person.

Claims

1. 1. A method in an infusion device, the infusion device comprising: a receptacle configured to receive a syringe; a plunger driver configured to releasably engage an end of a plunger of the syringe; a controller configured to control movement of the plunger driver in at least one direction, the controller configured to have functionality including a first functionality protected using a first authentication that is either enabled or not enabled to provide authenticated access; a user interface having a display and one or more input elements; Equipped with The method comprises: In response to a determination that the first authentication requiring an access code value is not enabled, generating a representation code value based on the first value and the second value using a representation code generation algorithm; generating an unlock code value based solely on said representation code value using an unlock code generation algorithm; displaying a display code via the display and forgoing displaying an unlock code; receiving a third value input by a user via the input element; enabling access to reset an access code via the user interface and / or enabling the first authentication in accordance with determining that the third value corresponds to the unlock code value; forgoing enabling access to reset an access code (PIN) via the user interface and forgoing enabling the first authentication in accordance with a determination that the third value does not match the unlock code value; A method comprising:

2. 2. The method of claim 1, further comprising: in response to detecting that the first authentication is enabled to provide authenticated access to the first function, the controller, via the user interface, including the access code value, enabling the plunger driver to be moved in at least one direction without requiring authentication.

3. receiving a fourth value via the one or more input elements; enabling access to the first feature in accordance with a determination that the fourth value corresponds to the access code value; forgoing enabling access to the first feature in response to a determination that the fourth value does not match the access code value; 3. The method of claim 1 or 2, comprising:

4. in response to determining that the fourth value does not match the access code value; the controller forgoing enabling the plunger driver to move in at least one direction and forgoing enabling the first function; and / or setting the first authentication to not be valid; The method according to any one of claims 1 to 3, comprising:

5. a first function secured using the first authentication; The method of any one of claims 1 to 4, comprising receiving, via the input element, one or more inputs corresponding to the settings in the controller for controlling infusion in the infusion device in accordance with the settings.

6. 6. The method of claim 1, further comprising the step of: setting the first authentication requesting the access code value to be invalid according to reaching and / or exceeding a threshold number of consecutive determinations that the fourth value does not correspond to the access code value.

7. upon determining that the third value does not match the unlock code value; generating a new representation code value based on the second value and based on a new acquisition of the first value from a generator; generating a new unlock code value in response to the newly generated display code; The method according to any one of claims 1 to 6, comprising:

8. The method of any one of claims 1 to 7, comprising the step of validating the first authentication in response to determining that the third value corresponds to the unlock code value and in response to detecting a reset of the access code.

9. The controller is configured to enter one or more states, including a first state, and / or detect one or more events, including a first event, and the method includes: Detecting that the controller has entered the first state and / or that the first event has been detected; and in response to detecting that the controller has entered the first state and / or that the first event has been detected, setting the first authentication requiring an access code value to not be valid; The method according to any one of claims 1 to 8, comprising:

10. the controller includes a generator for generating a time-varying value; the first value is obtained from the generator that generates a time-varying value that includes the first value; and the second value is based on a serial number associated with the infusion device; The method according to any one of claims 1 to 9.

11. The display code generation algorithm is configured to: one or more of multiplication, addition, and subtraction, excluding division; and The method according to any one of claims 1 to 10, wherein the combination is based on a bit shift.

12. 12. The method of any one of claims 1 to 11, wherein the time-varying value is repeatedly increased or decreased at a rate faster than once per 30 minutes, such as faster than once per minute, such as faster than once per second.

13. 13. The method of any one of claims 1 to 12, wherein the time-varying value is repeatedly increased or decreased at a rate slower than once per 100 milliseconds, such as at a rate of once per second or less, such as at a rate slower than once per minute.

14. The method according to any one of claims 1 to 13, wherein the display code value consists of a first number of characters and the unlock code consists of a second number of characters, the second number of characters being different from the first number of characters.

15. The infusion device is associated with a support facility, and the method comprises: At the support facility, receiving a value corresponding to the indication code; determining a code value identical to the unlock code value based on a value corresponding to the display code and an implementation of an unlock code generation algorithm; delivering the third value to a user based on a code value identical to the unlock code value; The method according to any one of claims 1 to 14, comprising:

16. The method of any preceding claim, wherein the support facility comprises a call center.

17. 1. An infusion device comprising: a receptacle configured to receive a syringe; a plunger driver configured to releasably engage an end of a plunger of the syringe; a controller configured to control movement of the plunger driver in at least one direction, the controller configured to have functionality including a first functionality protected using a first authentication that is either enabled or not enabled to provide authenticated access; a user interface having a display and one or more input elements; Equipped with An infusion device configured to carry out the method of any one of claims 1 to 12.

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